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Clinical Trials Lung Function Quality Control

The services available for clinical trials are listed below, but contact us and discuss your individual needs and allow us to prepare a quote for a scheme suitable for your clinical trial. Any one or all of these components can be used for your trial.

Introduction image Inspired Diagnostics Ltd is a UK registered respiratory physiology consultancy which has a portfolio of clinical respiratory physiology services including clinical trials accreditation and quality assurance/control of lung function testing for national and international studies. The company has experienced personnel who have been involved in several international multi-centre clinical trials assessing lung function test quality assurance for recent studies on inhaled insulin and respiratory drugs. Regulation agencies now routinely require that trials using respiratory drugs or drugs using the inhaled route to demonstrate changes in physiological status of the lungs must demonstrate quality control measures for the lung function tests being performed. Many documented studies in the literature or in safety studies have shown that the use of routine lung function tests (i.e. spirometry, lung volumes and gas transfer) image are sensitive indices of disease progression or therapeutic intervention. However, the variability in lung function measurements can be very high (>10%), unless high quality measurements, good staff training and an effective quality assurance process are in place. Recommendations from the ATS/ERS Guidelines (ERJ, 2005) on lung function testing recommend the use of quality control procedures in routine testing and especially in clinical trials. We can demonstrate that using lung function quality control can decrease this variation to about 5% for most measurements - but well within the ATS/ERS 2005 standards of repeatability criteria. Overview of the Service Here is an example of our full service, but we can adopt and tailor services to exactly what your study requires. The full service will establish accredited lung function testing centres that will act as testing centres for any clinical trials in their vicinity. Within each country/geographical region there could be a Key Lung Function Centre identified which will provide national support to centres throughout the study. image This full service will involve 6 phases;

(i) Production of protocols / standard operating procedures for lung function testing (ii) Accreditation of department (iii) Pre-study visits (iv) On-going quality control and assurance programme (v) On-line Site Questionnaire facility (vi) On-line Data Management & Tracking System
Standard operating procedures (SOP) Standard operating procedures can be prepared specifically to support the clinical trial protocol but these will contain standard SOPs for each test; spirometry SOP, lung volumes SOP, gas transfer SOP. Others SOPS can be written as required. Accreditation of department Firstly the department accreditation will involve the completion of a department questionnaire about the facilities, processes, equipment, measurements and staff so that an initial decision can be reached about suitability of the centre. A site response will be returned to the centre asking further information and offering recommendations for them to achieve suitability. They will then receive the standard operating procedure for the site visit Site Visit (SOP) prior to the visit. The centre will be judged against appropriate international recommendations in lung function testing (ATS/ERS, AARC, ARTP, ERS, ANZSRS, etc.) Pre-study Lung Function Centre Visits The site visit is essential for several reasons including; building a rapport between the Expert Lab and the centre, confirming the content of the imagequestionnaire, checking internal biological controls process and quality control, performing the external biological control, education and training the centre in the requirements of the testing for the study and preparing the centre for acceptance into the trial. The Site Visit Report will summarise all the information about the centre before an Accreditation Certificate is issued On-going Quality Assurance & Control The quality control process will involve daily quality checks on the day of any patient or biological control testing to include the volume and gas analyser calibration. Each week subjects will perform the biological control programme for all relevant tests to the study standard outlined in the SOPs. These will be sent to the Expert Lung Function Lab using the Quality Control Report Form. image Also, simulated flow volume loops will be performed. Every three months gas transfer simulator studies can also be performed to monitor the performance of the lung function equipment throughout the trial and will be submitted on the gas transfer simulator sheets. Quality assurance will be checked firstly by centres achieving the SOP standards for each patient visit and secondly by randomised sampling (5-100% of measurements) of raw patient traces and data from the Data Management by Central LF Lab. We can tailor the service your study requires to suit your budget - contact us today! Contact us